CN115697262A

CN115697262A - Ostomy bag filter

Info

Publication number: CN115697262A
Application number: CN202180023669.0A
Authority: CN
Inventors: R·E·皮特
Original assignee: Donaldson Co Inc
Current assignee: Donaldson Co Inc
Priority date: 2020-03-30
Filing date: 2021-03-26
Publication date: 2023-02-03
Also published as: US20230137568A1; WO2021202314A1; EP4125745A1

Abstract

Embodiments herein relate to ostomy bag filters. In embodiments, a filter assembly for venting gas from an ostomy bag is included, the filter assembly having a first layer, an adhesive layer, a sorption element and a second layer configured to be welded to the ostomy bag at an annular weld area surrounding a second opening; wherein the adhesive layer is configured to adhere to the first layer, the absorptive element, and the second layer such that the first opening overlaps the second opening; wherein the filter assembly is configured such that when the filter assembly is welded to the ostomy bag, gas from the ostomy bag flows axially through the sorption element and exits the filter assembly through the second opening; and wherein the perimeters of the first layer, the adhesive layer, and the second layer are substantially aligned. Other embodiments are also included herein.

Description

Ostomy bag filter

This application was filed as a PCT international patent application at 26.3.2021 in the name of Donaldson Company (a united states national Company, applicant designated by all countries), and american national Roger e.peet (inventor designated by all countries), and claims priority to U.S. provisional patent application No. 63/002,027 filed at 30.3.2020, the contents of which are incorporated herein by reference in their entirety.

Technical Field

The present invention relates to a suction breathing filter for a housing, such as a bag, more particularly an ostomy bag, and still more particularly to a vent filter and assembly for an ostomy bag.

Background

Ostomy (also known as colostomy, ileostomy or urostomy) is a procedure that is required when a person loses normal bladder or bowel function due to birth defects, disease, injury or other conditions. Cancer patients account for approximately 80% of ostomy. After an ostomy, body waste needs to be discharged through a stoma (surgical opening) in the abdominal wall and into a special appliance called an ostomy bag.

Depending on the diet, age, diagnosis, activity level and other variables of the patient, these wastes may contain large amounts of gases such as amines, ammonia and mercaptans. These gases can inflate the ostomy bag, causing concern or discomfort to the patient and compromising the seal between the skin and the ostomy bag itself.

In the past, ostomy bags have been equipped with a deodorizing gas filter so that flatus can be expelled from the bag, thereby reducing or preventing ballooning, while deodorizing escaping gas. In order to prevent such filters from becoming clogged and causing failure by liquid and/or solid bodily waste material within the bag, the filter is typically secured to the vent opening on the outer surface of the bag or protection is provided for the internally mounted filter in the form of a porous membrane extending over the filter. Typically, such membranes on internally mounted filters are hydrophobic and may also be oleophobic.

Ostomy bag filters may be of the axial flow type, or more commonly of the so-called run-off or side-flow type. These and other flow path types are described in commonly owned U.S. patent No. 8,979,811 issued 3-17-2015, attorney docket No. 758.7089USU1, the entire contents of which are incorporated herein by reference. For ostomy bag applications, a flow-through or sidestream filter is most common because it allows the construction of a low profile filter that also provides a longer flow path to deodorize flatus.

Disclosure of Invention

In an embodiment, a filter assembly for venting gas from an ostomy bag is included, the filter assembly having: a first layer configured to be gas permeable and liquid impermeable; an adhesive layer defining at least a first opening; a sorption element, which may include a gas-adsorbing material, disposed between the first layer and the adhesive layer; and a second layer, which may comprise a material having a melting temperature equal to or lower than 120 ℃ and defining at least a second opening, the second layer being configured to be welded to the ostomy pouch at an annular welding area surrounding the second opening; wherein the adhesive layer is configured to adhere to the first layer, the sorption element and the second layer such that the first opening overlaps the second opening, wherein the filter assembly is configured such that when the filter assembly is welded on the outlet opening of the ostomy bag, gas from within the ostomy bag flows axially through the sorption element and exits the filter assembly through the second opening, and wherein the perimeters of the first layer, the adhesive layer and the second layer are substantially aligned.

In an embodiment, the first layer may comprise Polytetrafluoroethylene (PTFE).

In an embodiment, the first layer may comprise a PTFE laminate.

In an embodiment, the adhesive layer may comprise a double-sided adhesive laminate.

In an embodiment, the adhesive layer may comprise a pressure sensitive adhesive.

In an embodiment, the adhesive layer is a coating on the second layer.

In an embodiment, the sorption element may comprise activated carbon.

In embodiments, the second layer may comprise Ethylene Vinyl Acetate (EVA), polyethylene (PE), or polypropylene (PP).

In an embodiment, the first opening and the second opening overlap at least about 70% of the length of the sorption element.

In an embodiment, the first opening and the second opening overlap at least about 25% of an area of a side of the sorption element.

In an embodiment, the adhesive layer further defines a third opening, and the second layer further defines a fourth opening overlapping the third opening.

In an embodiment, the first and second overlapping openings define a first filter assembly opening, wherein the third and fourth overlapping openings define a second filter assembly opening, and wherein the first and second filter assembly openings are substantially equal in area.

In an embodiment, a filter assembly array is included, the filter assembly array having: a plurality of filter assemblies, including each filter assembly having: a first layer configured to be gas permeable and liquid impermeable; an adhesive layer defining a first opening; a sorption element, which may include a gas-adsorbing material, disposed between the first layer and the adhesive layer; and a second layer, which may comprise a material having a melting temperature equal to or lower than 120 ℃ and defining a second opening, the second layer being configured to be welded to an ostomy pouch at an annular welding area surrounding the second opening; and a carrier that may include a carrier adhesive disposed on a first side of the carrier, wherein each of the filter assemblies is removably attached to the first side of the carrier.

In an embodiment, the carrier adhesive comprises a low tack adhesive.

In an embodiment, the carrier is wound into a filter assembly supply roll.

In an embodiment, wherein each of the plurality of filter assemblies is configured such that when the filter assembly is welded to the outlet opening of the ostomy bag, gas from within the ostomy bag flows axially through the sorption element and exits the filter assembly through the second opening.

In embodiments, further may comprise a gas impermeable barrier layer located between the first layer and the sorption element, the gas impermeable barrier layer being configured to block gas flow through the filter assembly from the direction of the first side of the sorption element, wherein each of the plurality of filter assemblies is configured such that when the filter assembly is welded on the exit opening of the ostomy bag, gas from within the ostomy bag flows laterally through the sorption element and exits the filter assembly through the second opening.

In an embodiment, the first layer may comprise Polytetrafluoroethylene (PTFE).

In an embodiment, the first layer may comprise a PTFE laminate.

In embodiments, the adhesive layer may comprise a double-sided adhesive laminate.

In embodiments, the adhesive layer may comprise a pressure sensitive adhesive.

In an embodiment, the adhesive layer is a coating on the second layer.

In an embodiment, the sorption element may comprise activated carbon.

In an embodiment, the overlapping first and second openings define a first filter assembly opening, wherein the overlapping third and fourth openings define a second filter assembly opening, and wherein the areas of the first and second filter assembly openings are substantially equal.

In an embodiment, a method for producing a filter assembly is included, the method comprising: providing a sheet of a first layer, an adhesive layer, an adsorbent layer, a second layer, and a carrier layer, wherein: the first layer is configured to be gas permeable and liquid impermeable, the adsorbent layer comprises a gas adsorbent material, the second layer comprises a material having a melting temperature equal to or lower than 120 ℃, and the carrier layer comprises a carrier adhesive disposed on an adhesive side of the carrier; bonding the second layer to the adhesive layer; simultaneously cutting through the second layer and the adhesive layer to form an opening; removably attaching the second layer to the adhesive side of the carrier layer; cutting the adsorbent layer into discrete adsorbent elements; placing one of the discrete adsorbent elements to cover the opening of the adhesive layer; bonding the first layer to the adhesive layer such that the absorptive element is disposed between the first layer and the second layer; and forming a perimeter around the adsorbent element by simultaneously cutting through the first layer, the adhesive layer, and the second layer, thereby obtaining a filter element disposed on the carrier layer.

In an embodiment, a method for generating a plurality of filter assemblies is included, the method comprising: providing a first layer sheet, an adhesive layer, an adsorbent layer sheet, a second layer sheet, and a carrier sheet, wherein: the first layer sheet is configured to be gas permeable and liquid impermeable, the adsorbent sheet comprises a gas adsorbent material, the second layer sheet comprises a material having a melting temperature equal to or lower than 120 ℃, and the carrier sheet comprises a carrier adhesive disposed on the adhesive side of the carrier; bonding the second ply to the adhesive layer to form a second layer subassembly having a first side and an opposite adhesive layer side; cutting through the second layer sub-assembly to define a plurality of filter assembly openings in the second layer sub-assembly; removably attaching the first side of the second layer subassembly to the adhesive side of the carrier sheet to form a first carrier subassembly having a first side and an opposing adhesive layer side; cutting the absorbent layer sheet into a plurality of absorbent elements; placing the plurality of adsorbent elements on the adhesive layer side of the first carrier sub-assembly such that each of the plurality of filter assembly openings is covered by one of the plurality of adsorbent elements, thereby forming a second carrier sub-assembly having a first side and an adhesive layer side; bonding the first layer to the adhesive layer side of the second carrier subassembly such that the adsorbent elements are disposed between the first layer and the second layer to form an uncut filter assembly; and forming a plurality of filter assembly perimeters around each of the adsorbent elements by simultaneously cutting through the first layer sheet, the adhesive layer, and the second layer sheet, but not through the carrier layer sheet, thereby resulting in a plurality of filter elements disposed on the carrier layer sheet.

In an embodiment, the method may further comprise: the plurality of filter elements disposed on the carrier layer are wound into a filter element supply roll.

In an embodiment, the adhesive layer comprises a pressure sensitive adhesive and winding the plurality of filter elements disposed on the carrier layer into a filter element supply roll compresses the first layer of sheet material, the adhesive layer, and the second layer of sheet material.

In an embodiment, the method may further comprise: unwinding the second layer of sheet material from a second layer supply roll, wherein the second layer of sheet material on the second layer supply roll comprises an adhesive layer on the adhesive layer side.

In an embodiment, the method may further comprise: forming a second layer sub-assembly at least 24 hours before forming the plurality of filter assembly perimeters.

In an embodiment, the method may further comprise: forming the plurality of filter assembly perimeters at least 24 hours before applying a filter element of the plurality of filter elements to an ostomy bag.

This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and the appended claims. Other aspects will become apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part hereof, and each of these aspects should not be considered in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents.

Drawings

Aspects may be more fully understood in conjunction with the following figures (drawings), in which:

fig. 1 is a top view of an ostomy pouch having a filter assembly according to various embodiments herein.

FIG. 2 is a top plan view of a first side of a filter assembly according to one embodiment.

Fig. 3 is a bottom plan view of a second side of the filter assembly of fig. 2 according to various embodiments herein.

FIG. 4 is a cross-sectional view of the filter assembly of FIG. 2 taken through section line 4-4 of FIG. 2 according to various embodiments herein.

Fig. 5 is an exploded view of components of the filter assembly of fig. 2 according to various embodiments herein.

Fig. 6 is an exploded view of an alternative component of the filter assembly of fig. 2 according to various embodiments herein.

Fig. 7 is a top plan view of a first side of another embodiment of a filter assembly having a single filter assembly opening according to various embodiments herein.

Fig. 8 is a top plan view of a first side of the filter assembly of fig. 2, with dashed lines showing components within the filter assembly, in accordance with various embodiments herein.

Fig. 9 is a bottom plan view of a second side of the filter assembly of fig. 2, with dashed lines showing components within the filter assembly, in accordance with various embodiments herein.

Fig. 10 is a cross-sectional view of the filter assembly of fig. 2 welded to an ostomy bag with the filter assembly having an axial flow path therethrough according to various embodiments herein.

Fig. 11 is a cross-sectional view of yet another embodiment of a filter assembly welded to an ostomy bag according to various embodiments herein, wherein the filter assembly has a lateral flow path therethrough.

Fig. 12 is a flow diagram of a method for manufacturing a filter assembly according to various embodiments herein.

Fig. 13 is a top view of a second layer subassembly according to various embodiments herein.

Fig. 14 is a top view of a second carrier subassembly according to various embodiments herein.

Fig. 15 is a top view of an uncut filter assembly according to various embodiments herein.

Fig. 16 is a top view of an array of filter assemblies on a release liner according to various embodiments herein.

Fig. 17 is a side view of a roll of filter assemblies on a release liner according to various embodiments herein.

While the embodiments are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings and will be described in detail. It should be understood, however, that the scope herein is not limited by the particular aspects described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

Detailed Description

Described herein is a filter assembly that, in certain embodiments, includes a filtration layer comprising an adsorbent material, and at least one gas impermeable outer membrane layer, referred to as a first layer. The first layer is heat sealable in some embodiments and microporous in some embodiments. The filter assembly has a low profile and is capable of selective gas adsorption, absorption, catalysis, or a combination thereof. This type of filter assembly may be placed over the vent as a vent assembly and is commonly referred to as an Adsorbent Breathing Filter (ABF).

ABF is most commonly used to seal air vents in liquid-tight enclosures. Vented ostomy bags, in which liquid and solid phase materials are trapped while allowing selected gases to escape, are particularly useful examples of filter assemblies described herein. ABF is also commonly used in sensors and electronics enclosures, with the emphasis of keeping solids and liquids outside the enclosure while allowing selected gas phase fluids to enter for cooling and/or sensing.

The filter assembly can be used with many different types of enclosures, including flexible and rigid. In one embodiment, the enclosure is a bag, which is a flexible enclosure made primarily of plastic. The filter assembly is particularly useful where it is used with an ostomy bag and will be described herein in this context for convenience. The filter assembly has two sides: i.e. the bag side or shell side to be sealed to an ostomy bag or other shell, and the outer side opposite the bag side. For convenience, the enclosure side of the filter assembly is referred to herein as the bag side, and the filter assembly will generally be discussed in the context of an enclosure bag (particularly an ostomy bag), although the concepts herein are equally applicable to other types of enclosures.

The filter assemblies described herein have been designed to eliminate unnecessary components from prior art arrangements, reduce the cost of the filter assembly, and provide complete functionality for the end user, as well as providing features for use during ostomy pouch manufacture. The filter assemblies described herein may also reduce the tendency of feces to clog the filter, thereby increasing the useful life of the filter, as compared to previous designs that included an expanded polytetrafluoroethylene (ePTFE) laminate on the bag side of the filter assembly. Eliminating the ePTFE laminate on the bag side also reduces the cost of the filter assembly.

Filter assembly

Referring now to fig. 1-3, fig. 1 shows a top view of an ostomy bag with a filter assembly, and fig. 2 and 3 show top and bottom views, respectively, of a filter assembly according to various embodiments herein. The ostomy bag 100 comprises an inner surface 102, an outer surface 104, and a stoma opening 106 into the interior of the ostomy bag. The stoma opening 106 is surrounded by a flange 108 where the ostomy bag is connected to the stoma of the user. The ostomy pouch 100 also defines a vent opening 110. The filter assembly 200 may be secured to the inside of the ostomy bag 100 such that the filter covers the vent opening 110. The outer shape of the filter assembly 200 is visible through the stoma opening 106 and is shown in dashed lines, where it is hidden by the top layer of the ostomy bag. The filter assembly 200 can have a second layer 204 secured to the bag and a first layer 202 opposite the second layer. The second layer 204 is visible in fig. 1 through the stoma opening and in fig. 3, while fig. 2 is a bottom plan view of the filter assembly, showing the second layer 204.

The filter assembly 200 may have any shape compatible with the ostomy pouch 100 and/or the patient's body. In various embodiments, the filter assembly 200 may be generally rectangular in shape. In various embodiments, the corners of the filter assembly 200 may be rounded. In an embodiment, a region of the filter assembly 200 is generally rectangular with a set of opposing curved sides. In various embodiments, the top of filter assembly 200 is formed by first layer 202.

Referring now to fig. 3, a bottom plan view of a second side of the filter assembly of fig. 2 is shown, in accordance with various embodiments herein. In various embodiments, the bottom of the filter assembly 200 is formed by the second layer 204. The second layer is configured to be bonded to an ostomy pouch. In various embodiments, the outer perimeter of the second layer 204 is substantially aligned with the outer perimeter of the first layer 202. The filter assembly 200 may include one or more filter assembly openings 306 extending through the second layer 204 of filter assemblies.

Referring now to fig. 4, a cross-sectional view of the filter assembly of fig. 2 taken through section line 4-4 is shown, in accordance with various embodiments herein. In various embodiments, the filter assembly 200 may include a first layer 202, an adhesive layer 410, an adsorbent element 408, and a second layer 204. As seen in fig. 4, the outer perimeters of the first layer 202, the adhesive layer 410, and the second layer 204 may be substantially aligned. In an alternative embodiment, the perimeter of the second layer 204 may fit within and be spaced apart from the perimeter of the first layer 202.

Referring now to fig. 5, an exploded view of components of the filter assembly of fig. 2 is shown, according to various embodiments herein. In various embodiments, the filter assembly 200 may include a first layer 202, an adhesive layer 410, an adsorbent element 408, and a second layer 204. As shown in fig. 5, the adhesive layer 410 may form different layers of the filter assembly 200. The adhesive layer may be disposed between the first layer and the adsorbent element when the filter assembly is in an assembled state. As shown in fig. 5, the adhesive layer 410 may have at least a first opening 409 and the second layer 204 may have at least a second opening 411. In various embodiments, the first opening 409 and the second opening 411 at least partially overlap and form at least one filter assembly opening 306 when the filter assembly 200 is in its assembled state.

Referring now to fig. 6, an exploded view of components of the filter assembly of fig. 2 is shown, according to various embodiments herein. In various embodiments, the filter assembly 200 may include a first layer 202, an adhesive layer 410, an adsorbent element 408, and a second layer 204. In some embodiments, the adhesive layer 410 may be integral with the second layer 204. As shown in fig. 6, the second layer 204 may include an adhesive coating or layer 410 facing the adsorbent element 408.

First layer

In various embodiments, filter assembly 200 may include a first layer 202. In various embodiments, the first layer is configured to be gas permeable. The first layer may be microporous. As used herein, the term "microporous" refers to a material comprising pores having a diameter of about 2 microns or less than 2 microns. In some embodiments, the first layer is also liquid impermeable. The first layer may comprise a variety of materials including, but not limited to, polytetrafluoroethylene (PTFE), layers comprising only PTFE, laminates comprising PTFE, and expanded PTFE, low density Polyethylene (PE), polyolefins, or porous membranes. In various embodiments, the first layer is sufficiently compliant to conform to the shape of the suction element 408.

The thickness of the first layer is at least 0.013mm in one embodiment and at most 0.09mm in one embodiment. In some embodiments, the thickness of the first layer 202 may be greater than or equal to 0.01mm, 0.02mm, 0.04mm, or 0.05mm. In some embodiments, the thickness may be less than or equal to 0.10mm, 0.08mm, 0.07mm, or 0.05mm. In some embodiments, the thickness may fall within a range of 0.01mm to 0.10mm, or 0.02mm to 0.08mm, or 0.04mm to 0.07mm, or may be about 0.05mm.

Adsorption element

In various embodiments, the filter assembly 200 may include a suction element 408. In various embodiments, the sorption element may take the form of: an adsorbent layer, an adsorbent section, an adsorbent material, an adsorbent sheet, and the like. In various embodiments, the adsorbent element comprises a gas adsorbent material. One embodiment of the adsorbent element incorporates activated carbon and a fibrous matrix containing finely divided activated carbon particles bound by fine fibers, such as electrospun polymeric fine fibers. The activated carbon and fibrous matrix are then laminated and/or encapsulated by various microporous and/or nonporous membranes to form an efficient and low profile ostomy vent capable of selective gas adsorption, catalysis, or various combinations.

In one embodiment, the adsorbent material is suspended in a web of material capable of roll-to-roll processing and manufacturing techniques. The term "web" is used to mean a thin, flexible material capable of being rolled up, typically in long webs, the length in the machine direction being much longer than the width in the cross-machine, vertical direction.

In one embodiment, the adsorbent material is suspended within a foam or felt material.

In one embodiment, the adsorbent material comprises a scrim substrate on which a layer of adsorbent particles (e.g., carbon particles) and fibers (e.g., fine fibers) are formed. Additional adsorbent particles are added with the fibrous layer to form the adsorbent material. In one embodiment, the scrim side of the adsorbent material faces the first layer.

The reactive or adsorptive particles remain with or intersperse the fibers. The combination of particles and fibers results in a material with the following advantages: increased diffusion to allow the use of smaller particles, thereby increasing the external surface area and hence reaction rate; and increasing the penetration into the reaction layer.

The low pressure drop and high efficiency of the particle and fiber configuration allows the filter to be configured such that the airflow passes through the face of the filter media in an axial configuration. The flexibility and thin profile of the activated carbon and fibre matrix based filter allows the ostomy product to more closely conform to the patient's body. In certain embodiments, the filters described herein comprise at least one sealable, liquid impermeable, gas permeable outer microporous membrane layer; in addition, the inner filter layer of adsorbent particles is substantially uniformly dispersed in the fine fiber web. In some embodiments, the filter further comprises a second porous outer cover layer.

In one embodiment, the carbon particle loading is between 100 and 500g/m ² In certain embodiments, the carbon particle loading is between 150 and 400g/m ² And in other embodiments, the carbon particle loading is between 200 and 300g/m ² In the meantime. Typically, the carbon particle loading is at least 50g/m ² Usually more than 100g/m ² And optionally greater than 200g/m ² 。

The thickness of the adsorbent element 408 having adsorbent particles substantially uniformly dispersed in the fine fibers is typically less than 5mm, alternatively less than 3mm, and desirably less than 2mm. In one embodiment, the adsorption element 408 has a thickness of at least 0.01 mm. In one embodiment, the suction element 408 has a thickness of no more than 10 mm. The adsorption element 408 may have a thickness of at least 0.25 mm. In one embodiment, the sorption element 408 has a thickness of at most about 6.35 mm. In one embodiment, the suction element 408 is about 1.27mm thick.

Second layer

In various embodiments, the filter assembly 200 may include a second layer 204. In various embodiments, the second layer 204 is configured to be liquid impermeable and gas impermeable.

The second layer 204 is preferably formed of a material that can be securely bonded to the ostomy bag 100. Ostomy bags are typically made of materials with low surface energy, such as Ethylene Vinyl Acetate (EVA) plastic. A low surface energy material is defined herein as a material having a surface energy of less than 36 dynes/cm (dynes/cm). In case the second layer is also made of EVA, these materials are compatible and a reliable bond can easily be formed. Alternatively, the second layer may be constructed of other compatible materials, including but not limited to Polyethylene (PE) or polypropylene (PP).

In various embodiments, the second layer comprises a material having a melting temperature equal to or less than 120 ℃. In some embodiments, the melting temperature may be less than or equal to 120 ℃, 118 ℃, 115 ℃, 112 ℃, or 110 ℃. In some embodiments, the melting temperature may fall within a range of 90 ℃ to 120 ℃, or 95 ℃ to 118 ℃, or 100 ℃ to 115 ℃, or 105 ℃ to 112 ℃, or may be about 110 ℃. The melting temperature of the second layer can be determined by using Differential Scanning Calorimetry (DSC), using a 10 mg sample and measurements during the second heating cycle instead of the first heating cycle.

In some embodiments of the ostomy bag, the wall of the ostomy bag is made of the same material as the second layer, which allows a good bonding by heat welding and similar melting temperatures. In some embodiments of the ostomy bag, the ostomy bag wall and the second layer of the filter assembly are both made of EVA.

In some embodiments of the ostomy bag, the ostomy bag wall is made of EVA and the second layer of the filter assembly is made of a material that thermally bonds well to EVA. In some embodiments, the second layer of the filter assembly is made of Polyethylene (PE) or polypropylene ether (PPE), both of which thermally bond well with EVA.

Adhesive layer

In various embodiments, the filter assembly 200 may include an adhesive layer 410. The adhesive layer 410 is configured to seal the second layer 204 to the first layer 202. This prevents leakage paths for liquid from the interior of the envelope around the first layer, for example between the first and second layers. The arrangement is designed such that the gas needs to travel through the adsorbent material as it exits the enclosure through the filter assembly.

In some embodiments, the adhesive layer 410 may be formed of an acrylic-based pressure sensitive adhesive. A commercially available example is acrylic adhesive 300MP from 3MTM of st paul, minnesota, usa. In some embodiments, the adhesive layer 410 may be formed of a silicone-based pressure sensitive adhesive. A commercially available example is double-sided adhesive tape 96042 from 3MTM, saint paul, mn, usa.

As shown in fig. 5, the filter assembly 200 may include different adhesive layers 410. In some embodiments, the adhesive layer comprises a pressure sensitive adhesive. In some embodiments, the adhesive layer is a double-sided adhesive laminate. In one approach, the adhesive layer 410 is bonded to the second layer 204 as an early step in the filter assembly manufacturing process.

Alternatively, as shown in fig. 6, the adhesive layer 410 may be integral with the second layer 204, for example provided as a coating on the second layer 204. In some embodiments, adhesive layer 410 comprises a pressure sensitive adhesive. In some embodiments, adhesive layer 410 is a double-sided adhesive laminate. In some embodiments, the adhesive layer 410 is a coating applied on the second layer 204. In one approach, the second layer 204 may be provided in roll form with the adhesive layer 410 already applied by its supplier as input to the filter assembly manufacturing process.

Filter assembly opening

In various embodiments, the adhesive layer 410 may include at least a first opening 409 and the second layer 204 may include at least a second opening 411. The first opening 409 and the second opening 411 are configured to at least partially overlap when the second layer 204 is bonded to the adhesive layer 410. The first opening 409 and the second opening 411 overlap to form at least one filter assembly opening 306. In various embodiments, gas from the ostomy bag may exit the filter assembly 200 through the filter assembly opening.

In various embodiments, the filter assembly 200 may have a plurality of filter assembly openings 306. Fig. 3 and 5-6 illustrate a filter assembly 200 having two filter assembly openings 306. In an alternative embodiment, FIG. 7 shows a filter assembly 200 having a single filter assembly opening. In some embodiments, the number of filter assembly openings 306 may be greater than or equal to one, two, three, four, or five (5) openings. In various embodiments, the area of the one or more filter assembly openings 306 may be generally rectangular. In various embodiments, the curvature of the one or more filter assembly openings 306 may match the curvature of the filter assembly. In embodiments, the area of the one or more filter assembly openings may be generally rectangular with a set of opposing curved sides. Other sizes, shapes and configurations of openings are conceivable to those skilled in the art.

The filter assembly opening 306 is sized to allow sufficient venting of gas from the ostomy bag 100. Referring now to fig. 9, a bottom plan view of the second side of the filter assembly of fig. 2 is shown with dashed lines illustrating components within the filter assembly according to various embodiments herein. An outer perimeter 814 of the sorption element is shown relative to the second layer 204. The suction element 408 has a length L _A And the one or more filter assembly openings 306 have an area A with one side of the adsorbent element _A At least 25% overlap of combined area A _O . In some embodiments, the length L of the one or more filter assembly openings _O May be greater than or equal to the length L of the suction element _A 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90% or may be an amount overlap that falls within a range between any of the foregoing values.

In various embodiments, the one or more filter assembly openings 306 can have an area A with one side of the adsorbent element _A At least 25% overlap of the combined opening area A _O . In some embodiments, the combined opening area A _O May be equal to or larger than the area A of one side of the adsorption element _A Or may be an amount that falls within a range between any of the foregoing values.

Filter assembly weld area

The welding area of the filter assembly defines the location where the second layer is attached to the wall of the ostomy bag by a welding process. The weld region does not overlap the adsorbent material in a top or bottom plan view of the filter assembly. In some examples, the weld region is an extent of the second layer that is not coextensive with the adsorbent material. The weld zone has an annular shape including an outer perimeter and an inner perimeter defining and surrounding the non-weld zone. The suction element is positioned within a region of the second layer corresponding to the non-welding region. The inner perimeter of the weld region may be spaced apart from the outer perimeter of the adsorbent material.

Referring now to fig. 8, a top plan view of a first side of the filter assembly of fig. 2 is shown with dashed lines illustrating components within the filter assembly according to various embodiments herein. In various embodiments, the filter assembly 200 may have a welding region 812, wherein an annular welding tool may contact the first layer 202 of the filter assembly and weld the second layer 204 of the filter assembly to the ostomy bag 100. The filter assembly 200 may have an outer perimeter 818 defining outer edges of the filter assembly, and an inner perimeter 816 defining locations where the first layer 202 contacts the adhesive layer 410 and the second layer 204. In various embodiments, the weld region 812 is an annular region disposed between the inner perimeter 816 and the outer perimeter 818. In some embodiments, the weld zone extends substantially the entire distance between the inner perimeter 816 and the outer perimeter 818. Alternatively, the weld region 812 may span a portion of the distance between the inner perimeter 816 and the outer perimeter 818, such as at least or about 50%, 75%, 80%, 85%, 90%, 95%, or 98%. As shown in FIG. 8, the adsorbent element outer perimeter 814 is disposed inside the filter assembly inner perimeter 816. The area inside the inner perimeter 816 may form a non-welded area. In some embodiments, the inner perimeter 816 is spaced apart from the sorption element outer perimeter 814 by a first edge distance. In some examples, the inner perimeter of the weld area may serve as the filter assembly inner perimeter 816. In other examples, the inner perimeter of the weld region may be spaced apart from the adsorbent element outer perimeter 814 by a second rim distance that is greater than the first rim distance.

In various embodiments, the second layer of the filter assembly does not comprise any adhesive on the first side which is connected to the carrier layer and which is to be bonded to the ostomy bag. In these embodiments, the carrier layer may still include an adhesive that removably secures the second layer of the filter assembly to the carrier layer. However, in various embodiments, the bag side of the filter assembly is free of adhesive.

Gas flow through filter assembly

Ostomy bag filters may be of the axial flow type, or more commonly of the so-called run-off or side-flow type. These and other flow path types are described in commonly owned U.S. patent No. 8,979,811 issued 3-17-2015, attorney docket No. 758.7089USU1, the entire contents of which are incorporated herein by reference. For ostomy bag applications, a radial or lateral flow type filter is most common because it allows the construction of a low profile filter that also provides an expanded flow path to deodorize flatus. The radial flow type and lateral flow type filters have a large adsorption path length, thereby improving adsorption performance. However, a larger adsorption path length is expected to reduce the air flow through the filter. In contrast, axial flow filters are expected to have higher levels of air flow due to the shorter adsorption path length.

Fig. 10 is a cross-sectional view of the filter assembly of fig. 2 welded to an ostomy bag with the filter assembly having an axial flow path therethrough according to various embodiments herein. In various embodiments, the filter assembly 200 may include a first layer 202, an adhesive layer 410, an adsorbent element 408, and a second layer 204. The filter assembly 200 may be welded to the ostomy bag 100 such that the second layer 204 of the filter assembly is bonded to the inner surface 102 of the ostomy bag along the annular welding area 812. The filter assembly 200 is positioned in alignment with the vent opening 110 of the ostomy bag 100. In various embodiments, gas from the ostomy bag enters the filter assembly 200 through the first layer 202 and exits the filter assembly through the filter assembly opening 306. The arrows in fig. 10 represent exemplary gas flow paths along which gas flows axially through filter assembly 200. In an embodiment, gas from the ostomy pouch 100 enters the filter assembly 200 through the first layer, flows axially through the adsorbent layer, and exits the filter assembly through the filter assembly opening 306.

Referring now to fig. 11, a cross-sectional view of yet another embodiment of a filter assembly welded to an ostomy bag according to various embodiments herein is shown, wherein the filter assembly has a lateral flow path therethrough. In various embodiments, the filter assembly 200 may include a first layer 202, an adhesive layer 410, an adsorbent element 408, and a second layer 204. The filter assembly 200 may be welded to the ostomy bag 100 such that the second layer 204 of the filter assembly is bonded to the inner surface 102 of the ostomy bag along the annular welding area 812. The filter assembly 200 is positioned in alignment with the vent opening 110 of the ostomy bag 100. As shown in fig. 11, the filter assembly may include a barrier layer 1014 disposed between the first layer 202 and the adsorbent element 408. The barrier layer 1014 is configured to block gas flow through the filter assembly from the direction of the first side of the adsorbent element 408. The barrier layer 1014 is configured to be gas impermeable such that gas from the ostomy pouch may only enter the adsorbent element 408 in the absence of the barrier layer. The arrows in fig. 11 represent exemplary gas flow paths along which gas flows laterally through filter assembly 200. In various embodiments, gas from the ostomy pouch 100 enters the filter assembly 200 through the gas permeable first layer, enters the sorption element 408 through the side where the barrier layer 1014 is not present, flows laterally through the sorption element 408, and exits the filter assembly through the filter assembly opening 306.

Method for producing an array of filter assemblies

Referring now to fig. 12, a method for manufacturing a filter assembly according to various embodiments herein is illustrated. The method 1300 may include providing, in step 1302, a first layer sheet 1202, an adhesive layer 1208, an absorbent layer sheet, a second layer sheet 1204, and a carrier sheet 1210. The sheets provided in the method may be used to produce one or more filter assemblies 200. In various embodiments, the first layer of sheet material is configured to be gas permeable and liquid impermeable, the adsorbent layer comprises a gas adsorbent material, the second layer comprises a material having a melting temperature equal to or less than 120 ℃, and the carrier layer comprises a carrier adhesive disposed on the adhesive side of the carrier. In some embodiments, the second sheet 1204 and the adhesive layer 1208 are provided separately. In some embodiments, the second sheet 1204 and the adhesive layer 1208 are provided as a single sheet such that the second sheet is bonded to the adhesive layer.

The method 1300 may include bonding a second ply 1204 to an adhesive layer 1208 to form a second layer subassembly 1400 having a first side 1205 and an opposing adhesive layer side 1209 in step 1304. The term "subassembly" is used to refer to the output of a step in the production process of a single filter assembly or an array of multiple filter assemblies. In some embodiments, the adhesive layer 1208 comprises a pressure sensitive adhesive, and the second layer subassembly 1400 is formed by compressing the second layer of sheeting 1204 and the adhesive layer 1208. One skilled in the art can envision various ways of bonding the second sheet 1204 to the adhesive layer 1208, including pressure bonding, thermal bonding, and the like. In an alternative embodiment, the second layer of laminate 1204 and the adhesive layer 1208 are provided to a pre-bonding process such that the second layer subassembly 1400 is already formed and this step may be omitted. In various embodiments, in step 1316, the second tier sub-component 1400 is formed at least 24 hours before forming the plurality of filter component perimeters. In some embodiments, in step 1316, the second tier sub-component 1400 is formed more than or equal to 1 day, 4 days, or 7 days, or an amount within a range between any of the foregoing values, before forming the plurality of filter component perimeters.

Pre-bonding the second ply 1204 to the adhesive layer 1208 increases the hold time between the two layers. In the context of this method, the holding time is defined as the length of time that one material is in contact with another material. In various embodiments, the longer hold time increases the bond strength between the second sheet 1204 and the adhesive layer 1208. In some embodiments, the holding time may be greater than or equal to 1 day, 4 days, 7 days, or may be at least 1 day, 2 days, 3 days, or 4 days, or may be an amount falling within a range between any of the foregoing values. In some embodiments, the holding time may be less than or equal to 24 hours, 20 hours, 16 hours, 12 hours, 8 hours, 4 hours, or 1 hour, or may be an amount falling within a range between any of the foregoing values.

In some embodiments, pressure is applied to the second layer subassembly 1400 during the hold time. In an embodiment, the pressure is applied by rolling the second layer subassembly 1400 into a supply roll. Other means of applying pressure are possible, including applying rollers, weights, etc. to the second layer subassembly 1400. In some embodiments, the pressure applied to the second layer subassembly 1400 can be greater than or equal to 1 kilopascal (kPa), 11kPa, 21kPa, 30kPa, 40kPa, or 50kPa. In some embodiments, the pressure applied to the second layer subassembly 1400 can be less than or equal to 100kPa, 90kPa, 80kPa, 70kPa, 60kPa, or 50kPa. In some embodiments, the pressure may fall in a range of 1kPa to 100kPa, or 11kPa to 90kPa, or 21kPa to 80kPa, or 30kPa to 70kPa, or 40kPa to 60kPa, or may be about 50kPa. In some embodiments, the second layer subassembly 1400 can be pressurized for greater than or equal to 1 day, 4 days, 7 days, or can be at least 1 day, 2 days, 3 days, or 4 days, or can be an amount within a range between any of the foregoing values. In some embodiments, the second layer subassembly 1400 can be pressurized for less than or equal to 24 hours, 20 hours, 16 hours, 12 hours, 8 hours, 4 hours, or 1 hour, or can be an amount falling within a range between any of the foregoing values.

Method 1300 may include, in step 1306: the second layer subassembly 1400 is cut through to define a plurality of filter assembly openings 306 in the second layer subassembly. In various embodiments, the filter assembly opening 306 is cut with a knife, but other cutting means are envisioned by those skilled in the art, including die cutting, laser cutting, and the like. Various numbers, shapes and configurations of filter assembly openings 306 may be cut into the second layer sub-assembly. The filter assembly openings 306 may be cut in groups, including 1, 2, or more openings. Each set of filter assembly openings 306 may receive one filter assembly 200. In various embodiments, the set of filter assembly openings 306 are spaced far enough apart to accommodate the outer perimeter 818 of the filter assembly. In some embodiments, waste material generated by cutting the filter assembly openings 306 is subsequently removed from the second layer subassembly 1400. The waste may be removed using a vacuum device, a picker device, a human operator, or a portion of the cutting equipment, or other techniques may be used.

Referring now to fig. 13, a top view of a second layer subassembly 1400 is shown in accordance with various embodiments herein. The second layer subassembly 1400 can include a second layer of laminate 1204 and an adhesive layer 1208 bonded together. The second layer subassembly 1400 can include a first side 1205 (not visible in this view) and an adhesive layer side 1209. In various embodiments, the first side 1205 of the second layer subassembly 1400 is formed from the second layer of sheet material 1204. In various embodiments, the adhesive layer side 1209 of the second layer subassembly is formed by an adhesive layer 1208. In various embodiments, a plurality of filter assembly openings 306 are cut in the second layer subassembly 1400.

Method 1300 may include, in step 1308: the first side 1205 of the second layer subassembly 1400 is removably attached to the adhesive side of the carrier sheet 1210 to form a first carrier subassembly 1450 having a first side and an opposing adhesive layer side. In various embodiments, the carrier sheet 1210 includes a low tack adhesive or an electrostatic adhesive material to removably attach the second layer subassembly 1400 thereto. In the context of the present application, a low tack adhesive is defined as an adhesive that can attach an object (such as a filter assembly or the like) to an adhesive carrier such that the object adheres to the adhesive carrier when pressure is applied, the object remains in place as the adhesive carrier moves, and the object can be removed from the adhesive carrier without damaging the object or leaving a substantial amount of adhesive on the surface of the object. In some embodiments, the adhesive side of the carrier sheet 1210 includes a pressure sensitive adhesive, and the first carrier subassembly 1450 is formed by compressing the second layer subassembly 1400 to the adhesive side of the carrier sheet 1210.

Method 1300 may include, in step 1310: the adsorbent sheet is cut into a plurality of adsorbent elements 408. In various embodiments, the suction elements 408 are cut from the suction sheet laminate with a knife, but other cutting means are envisioned by those skilled in the art, including die cutting, laser cutting, and the like. In various embodiments, the sorption element may be cut before or during

steps

1304, 1306, or 1308.

Method 1300 may include, in step 1312: the plurality of adsorbent elements 408 are placed on the adhesive layer side of the first carrier subassembly 1450 such that each of the plurality of filter assembly openings is covered by one of the plurality of adsorbent elements, thereby forming a second carrier subassembly 1500 having a first side 1205 and an adhesive layer side 1209. In various embodiments, suction elements 408 are placed over each set of openings cut in step 1306. In some embodiments, each adsorbent element 408 covers a single filter assembly opening 306. In other embodiments, each adsorbent element covers two, three, or more filter assembly openings 306 that make up a set of filter assembly openings. In various embodiments, the adhesive layer 1208 holds the adsorbent element 408 in place on the second carrier subassembly 1500.

Referring now to fig. 14, a top view of a second carrier subassembly 1500 is shown in accordance with various embodiments herein. The second carrier subassembly 1500 may include a first side 1205 and an adhesive layer side 1209. In various embodiments, the first side 1205 of the second carrier subassembly 1500 is formed by a carrier sheet 1210, while the adhesive layer side 1209 of the second carrier subassembly is formed by an adhesive layer 1208. The second carrier subassembly 1500 is formed by placing the plurality of adsorbent elements 408 on the adhesive layer side 1209 of the first carrier subassembly 1450 such that each set of filter assembly openings 306 is covered by one of the plurality of adsorbent elements 408. As shown in fig. 14, the adsorbent elements are placed on the second carrier subassembly 1500 such that each adsorbent element 408 is substantially concentric with each set of filter assembly openings 306.

In some embodiments, the carrier sheet 1210 is joined to the second layer subassembly 1400 prior to cutting the filter openings. In other embodiments, the carrier sheet 1210 is joined to the second layer subassembly 1400 after the filter openings are cut, as shown in the flow chart of fig. 12.

Method 1300 may include, in step 1314: the first layer is bonded to the adhesive layer side 1209 of the second carrier subassembly 1500 such that the adsorbent element 408 is disposed between the first and second layers to form an uncut filter assembly 1600. In some embodiments, the adhesive layer 1208 comprises a pressure sensitive adhesive, and the uncut filter assembly 1600 is formed by compressing the first layer sheet 1202 and the adhesive layer 1208. The first layer sheet 1202 and the adhesive layer 1208 may be compressed by rollers, weights, or the like.

Method 1300 may include, in step 1316: a plurality of filter assembly perimeters 818 are formed around each adsorbent element 408 by simultaneously cutting through the first layer sheet 1202, the adhesive layer 1208, and the second layer sheet 1204, but not through the carrier sheet 1210, resulting in a plurality of filter elements 200 disposed on the carrier sheet 1210. In various embodiments, the first layer, the second layer, and the adhesive layer have outer perimeters that are substantially aligned such that each filter assembly perimeter 818 may be formed in a single cut. In some embodiments, the number of filter assembly perimeters cut in the uncut filter assembly 1600 may be greater than or equal to 1, 10, 20, 30, 40, or 50 perimeters, or may be an amount that falls within a range between any of the foregoing values.

Referring now to fig. 15, a top view of an uncut filter assembly 1600 is shown, according to various embodiments herein. In various embodiments, the uncut filter assembly 1600 includes a first layer of sheet 1202, a second layer of sheet 1204, an adhesive layer 1208, a carrier sheet, and one or more adsorbent elements 408 bonded together.

The method may further comprise: the waste matrix is removed after cutting the filter assembly perimeter 818 in step 1316. In various embodiments, the scrap matrix includes excess material from the first layer of sheet 1202, the second layer of sheet 1204, and the adhesive layer 1208. The waste may be removed using a vacuum device, a picker device, a human operator, or a portion of the cutting equipment, or other techniques may be used.

After removal of the waste substrate, the array of filter assemblies 200 remains removably attached to the carrier 1210. Such an array can be seen in fig. 16. Removably attached to the carrier means that the filter assembly can be easily removed from the carrier 1210 without damaging the carrier 1210 or the filter assembly.

In various embodiments, the method comprises: the plurality of filter assembly perimeters are formed at least 24 hours before applying the filter assemblies 200 of the filter assembly array 1700 to the ostomy bag 100. In some embodiments, the method comprises: the filter assembly is formed on the carrier 1210 by an amount that is at least greater than or equal to 1 day, 4 days, or 7 days, or falls within a range between any of the foregoing before the filter assembly 200 is applied to the ostomy bag 100.

In some embodiments, allowing the array of filter elements to remain intact increases the retention time between the layers. In the context of this method, the holding time is defined as the length of time that one material is in contact with another material. In various embodiments, the longer hold time increases the bond strength between the first layer 202, the second layer 204, the adhesive layer 410, and the adsorbent element 408 of each filter assembly 200. In some embodiments, the holding time may be greater than or equal to 1 day, 4 days, or 7 days, or may be an amount falling within a range between any of the foregoing values. In some embodiments, the holding time may be less than or equal to 24 hours, 20 hours, 16 hours, 12 hours, 8 hours, 4 hours, or 1 hour, or may be an amount falling within a range between any of the foregoing values.

Referring now to fig. 16, a top view of an array 1700 of filter assemblies according to various embodiments herein is shown. The filter assembly array 1700 includes one or more filter assemblies 200 removably attached to a carrier sheet 1210. The carrier sheet 1210 may include a low tack adhesive or an electrostatic adhesive material to hold the filter assembly 200 to the carrier layer sheet. The filter assembly array of fig. 16 includes one filter assembly 200 per row. However, a filter assembly array 1700 having two or more filter assemblies 200 per row is possible.

In some embodiments, pressure is applied to the filter assembly array 1700 during the hold time. In an embodiment, the pressure is applied by winding the filter assembly array 1700 into a filter element supply roll 1220. Other means of applying pressure are possible, including applying rollers, weighted objects, etc. to the filter assembly array 1700. In some embodiments, the pressure applied to the second layer subassembly 1400 can be greater than or equal to 1kPa, 11kPa, 21kPa, 30kPa, 40kPa, or 50kPa. In some embodiments, the pressure applied to the second layer subassembly 1400 can be less than or equal to 100kPa, 90kPa, 80kPa, 70kPa, 60kPa, or 50kPa. In some embodiments, the pressure may fall within a range of 1kPa to 100kPa, or 11kPa to 90kPa, or 21kPa to 80kPa, or 30kPa to 70kPa, or 40kPa to 60kPa, or may be about 50kPa. In some embodiments, the second layer subassembly 1400 can be pressurized for greater than or equal to 1 day, 4 days, or 7 days, or can be an amount falling within a range between any of the foregoing values. In some embodiments, the second layer subassembly 1400 can be pressurized for less than or equal to 24 hours, 20 hours, 16 hours, 12 hours, 8 hours, 4 hours, or 1 hour, or for a duration that falls within a range between any of the values recited above.

Referring now to fig. 17, a top view of a roll of filter arrays according to various embodiments herein is shown. The method may further comprise: a plurality of filter elements disposed on a carrier layer are wound into a filter element supply roll 1220. In various embodiments, the adhesive layer 410 of each filter assembly 200 comprises a pressure sensitive adhesive, and winding the plurality of filter assemblies 200 disposed on the carrier sheet 1210 into the filter element supply roll 1220 compresses the first layer 202, the adhesive layer 410, and the second layer 204.

The filter assembly may then be coupled to an ostomy bag.

Method of coupling a filter assembly to an ostomy bag

Referring now to fig. 1, a top view of an ostomy bag with a filter assembly according to various embodiments herein is shown. The ostomy bag 100 comprises a stoma opening 106 into the inner surface 102 of the ostomy bag. The stoma opening 106 is surrounded by a flange 108 where the ostomy bag is connected to the stoma of the user. The ostomy pouch 100 also defines a vent opening 110.

The filter assembly 200 has a second layer 204 configured to be coupled to the ostomy bag 100, and a first layer 202 opposite the second layer. The filter assembly 200 further comprises a welding area 812 surrounding the adsorption element 408 and the filter assembly opening 306, wherein the filter assembly may be welded to the ostomy bag 100.

The filter assembly 200 is removed from the carrier sheet 1210 to expose the second layer 204 of the filter assembly. The filter assembly 200 is then placed on the vent opening 110 at the surface of the ostomy bag 100 such that the second layer 204 of the filter assembly contacts the bag surrounding the vent opening. The removal of the filter assembly and the placement of the filter assembly on the ostomy bag may be done manually by a person or in an automated manner using a machine.

After the filter assembly 200 is placed on the ostomy bag 100, a permanent seal is formed between the filter assembly and the ostomy bag. The permanent seal may be formed by heat sealing, radio frequency welding or ultrasonic welding. The permanent seal may be formed using a ring weld tool. The permanent seal prevents gas or liquid from bypassing the filter assembly 200. The seal is achieved by applying energy to the filter assembly 200, in particular the second layer 204, at the weld area 812, thereby forming a bond with the material of the ostomy pouch 100. The weld region may be annular and include an inner perimeter defining an open area that accommodates the footprint of the suction element 408. In various embodiments, the manufacturing process does not apply heat or other energy to the sorption element 408. Thus, in these embodiments, the bonding tool is configured to apply energy in a circular pattern and not to apply energy to the sorption element 408. The welding tool may be contacted with the filter assembly manually by a human or in an automated manner using a machine.

In one embodiment, the second layer 204 of the filter assembly 200 is adhered to the inner surface 102 of the ostomy pouch 100 over the vent opening 110. In another embodiment, the second layer 204 of the filter assembly 200 is adhered to the outer surface 104 of the ostomy pouch 100 over the vent opening 110.

The described embodiments allow for a convenient and efficient assembly method with a highly reliable seal between the ostomy bag 100 and the filter assembly 200. One of the most convenient ways of attaching the filter assembly 200 to the ostomy bag 100 is to use only a pressure sensitive adhesive to form a seal between the ostomy bag and the filter assembly. Only pressure sensitive adhesive is used without heat sealing, and no equipment is required for creating the seal. The craftsman of the assembly bag only needs to expose the adhesive and place the filter over the vent opening. In contrast, using a heat sealing process requires preparing the heat sealing equipment, carefully placing the filter over the vent opening, and maintaining the typically small, lightweight filter in this position while precisely applying the heat sealing equipment. However, ostomy bags are often made of materials with low surface energy, such as Ethylene Vinyl Acetate (EVA) plastic, as the low surface energy of the material makes it easy to completely evacuate the ostomy bag when necessary. The low surface energy of the bag material, however, leads to concerns about unreliable pressure sensitive adhesive seals. Any leakage of the filter assembly is unacceptable. A low surface energy material is defined herein as a material having a surface energy below 36 dynes/cm.

Thus, heat sealing the filter assembly to the ostomy bag is a preferred method over using an adhesive to attach the filter assembly to the ostomy bag. The reliability of adhesive-only seals using pressure-sensitive adhesives is problematic.

Additional options for materials and manufacturing methods are described in commonly owned U.S. patent No. 8,979,811 issued 3-17-2015, attorney docket No. 758.7089USU1, the entire contents of which are incorporated herein by reference.

Method for producing at least one filter assembly

The method for manufacturing the filter assembly array has been described above in detail. Methods for producing one or more filter assemblies are also contemplated. Aspects of the system/device operations described elsewhere herein may be performed as operations of one or more methods according to various embodiments herein.

In an embodiment, a method for manufacturing a filter assembly is included. The method can comprise the following steps: a sheet of a first layer, an adhesive layer, an adsorbent element, a second layer and a carrier layer is provided. In some embodiments, the first layer is configured to be gas permeable and liquid impermeable, the sorption element comprises a gas-adsorbing material, the second layer comprises a material having a melting temperature equal to or less than 120 ℃, and the carrier layer comprises a carrier adhesive disposed on the adhesive side of the carrier. The method can comprise the following steps: the second layer is bonded to the adhesive layer. The method can comprise the following steps: the second layer and the adhesive layer are cut through simultaneously to form an opening. The method can comprise the following steps: the second layer is removably attached to the adhesive side of the carrier layer. The method can comprise the following steps: the adsorbent element is cut into discrete adsorbent elements. The method can comprise the following steps: one of the discrete adsorbent elements is placed to cover the opening of the adhesive layer. The method can comprise the following steps: the first layer is bonded to the adhesive layer such that the adsorbent element is disposed between the first layer and the second layer. The method can comprise the following steps: a perimeter is formed around the adsorbent element by simultaneously cutting through the first layer, the adhesive layer, and the second layer, resulting in a filter element disposed on the carrier layer, thereby creating a filter assembly.

Polymer fine fiber

As noted above, in certain embodiments, the adsorbent elements 408 or filter media described herein utilize a fibrous matrix having activated carbon particles or fibers incorporated therein, such as shown for example as electrospun polymeric fine fibers. These fine fibers are also known as nanofibers. Additional binders or other inactive materials are generally not required to build the activated carbon and fiber matrix. As depicted in the photomicrograph, combining particles with fine fibers minimizes void space, thereby achieving near optimal adsorption capacity per given volume while providing the tortuous path required for gas diffusion. The soft, tough, and flexible nature of fine fibers makes activated carbon and fibrous matrices ideal for use as wearable adsorbents/absorbents.

Fibrous matrices that can be used are described in published PCT patent application WO 2007/095363, the entire contents of which are incorporated herein by reference. The fibers have a diameter of about 0.001 to about 2 microns, 0.001 to about 1 micron, 0.001 to about 0.5 micron, or 0.001 to about 5 microns,

small diameter fine fibers can be made using a variety of techniques. One method involves passing the polymeric material through fine capillaries or openings as a molten material, or in a solution that is subsequently evaporated. The fibers may also be formed by using "spinnerets" typically used to make synthetic fibers such as nylon. Electrospinning is generally the method of choice for forming the fine fiber nonwoven webs of the present invention. Such techniques involve the use of hypodermic needles, nozzles, capillaries or movable emitters. These structures provide a liquid solution of the polymer which is then attracted to a collection zone by a high voltage electrostatic field. As the material is pulled from the emitter and accelerated through the electrostatic zone, the fibers become very fine and can form a fibrous structure by solvent evaporation.

Another method involves the use of meltblown plastic or polymeric materials to produce a substantially uniformly dispersed fine fiber web. In general, meltblown fibers that are generally useful in accordance with the present invention are air laid continuously extruded fibers that are bonded to one another to form a sheet of filter material. The adsorbent particles of the present invention may be substantially uniformly dispersed in the fine fiber web. Plastics such as polypropylene, polystyrene and polyester may be used.

Incorporation of adsorptive and reactive particles

In an exemplary process, the particles are incorporated into the fine fiber nonwoven, typically by feeding the particles into a stream of polymeric solution using a volumetric screw feeder with an auger. In some embodiments, it is advantageous to further use a deflocculator to separate agglomerated particles. These particles are then deposited with the polymer solution and entangled in a fine fiber network formed after drying the polymer solution. In typical embodiments, the particles are activated carbon.

It will be appreciated that more than one type of particulate may be readily incorporated into the web of the present invention by providing a mixture of particulates in a positive displacement screw feeder, or by providing more than one feeder to provide the particulates to a flow of polymer solution. In this way, it is easy to incorporate different particles into the web.

Various embodiments allow for the use of webs comprising fine fibers and reactive, adsorptive or absorptive, inert or chemically modified particles. The chemical modification is a chemical or thermal treatment of the polymer, fibers and/or particles, or a chemical impregnation of the particles. It also includes mixing an impregnant into the fiber/particle web. The fluid (typically a gas) passing through the web interacts with the chemically or thermally modified web components. The active particles may react with, absorb, or adsorb a portion of the fluid. It allows selective chemical reaction of specific compounds or substances in the fluid with other compounds or substances attracted or trapped on the surface. The surface of the particles may also act as a catalyst by providing active sites that catalytically alter the species passing through the mesh.

The particles may be impregnated with one or more impregnants, such as sodium hydroxide alone to impregnate activated carbon to remove H ₂ S, or by impregnation with a mixture of sodium hydroxide and potassium iodide. The latter composition has a higher adsorption capacity and H than activated carbon impregnated with sodium hydroxide ₂ And S removal efficiency. It is believed that potassium iodide catalytically or synergistically enhances the effect of sodium hydroxide. Potassium iodide acts as an oxidant to promote H ₂ S is oxidized to sulfur. In this particular case, the concepts taught herein may be used as a method for removing H ₂ S, wherein the net and its composition of the present invention will provide the conditions required for ostomy bag filters, e.g. low flow, low pressure drop, high H ₂ And (4) S capacity. Other useful impregnating agents include citric acid, potassium hydroxide, potassium carbonate, sodium carbonate, potassium bicarbonate, sodium bicarbonate, and/or moisture, among others. These compounds may be impregnated on the particles or mixed with the web components.

Some examples of activated carbon impregnants and their applications include: impregnation of activated carbon with potassium carbonate to remove acid gases (HCl, HF, SO) ₂ 、H ₂ S、NO ₂ ) (ii) a Impregnation of activated carbon with potassium iodide to remove H ₂ S and PH ₃ (ii) a Impregnation of activated carbon with iron oxide to remove H ₂ S and mercaptan; and impregnating the activated carbon with potassium permanganate to remove H from the oxygen deficient gas ₂ And S. In some embodiments, the web is targeted to different applicationsCombinations of internally applied particles with different impregnating agents are also suitable. For example, a mixture of two activated carbons may be used.

The presence of water in combination with many of the above-specified impregnants increases H ₂ And (4) removing S. Water can be stored on the carbon surface or within the mesh by pre-wetting, or by using an impregnant or other adsorbent that attracts water vapor to its surface during application. Several types of adsorbents can be used to cover the desired humidity range and include molecular sieves, activated alumina, silica gel and activated carbon. These adsorbent materials may be further modified by oxidation, heating or impregnation. Impregnation is usually carried out with alkali metal sulfates, citric acid, alkali metal carbonates, alkali metal bicarbonates, lithium and sodium chloride, calcium chloride and/or mixtures thereof.

Water-absorbing particles may also be added to enable water absorption to low humidity or water storage. These water-absorbing particles may release some moisture under dry conditions. The presence of the released water can then increase H under dry conditions ₂ And (5) removing the S.

In addition to using particles that have been impregnated or coated with reactive species, it should be clear that these modifications can be made after the web and structure are formed. Imparting reactivity to the particles and webs after formation of the fibrous webs and structures can be accomplished using a variety of different coating processes. Such as spray coating, dip coating, aerosol deposition, chemical vapor deposition, and vacuum coating. The final step may involve a drying process, which may or may not include heat treatment, gas purging or vacuum methods.

In addition, the chemical composition of the walls of the first layer can be made to adsorb acidic, basic and organic substances as well as water vapor, as well as several specific classes of compounds, including reactive carbonyl compounds such as formaldehyde, acetaldehyde and acetone. These reactive materials may be held together with a binder or fibers to encapsulate or simply contain the particles. In addition, additional scrim materials may be attached to hold the reactive material in place and minimize particle shedding. The reactive material may also be sandwiched between scrim layers. The scrim may help create channels or spaces between the layers. This can be achieved by a high loft scrim material with the proper spacing and ability to hold all reactive particles in the media.

Additional functional layers

In addition to the nonwoven fine fiber composite web, it may also be advantageous to provide the web with one or more additional functional layers. The functional layer may be a coating or a separately formed material layer. For example, a microporous layer, a foam layer, an expanded polytetrafluoroethylene layer, a water barrier layer or coating, an odor masking layer or coating, or a combination thereof may be disposed on one or both sides of the nonwoven fine fiber composite web of the present invention.

Such additional layers may add additional functionality to the web when the functionality is built into the web as it is formed and not practical. For example, it may be desirable not to provide the web with a fluoride coating in order to adhere the web to the substrate. However, where oil repellency is desired in the application, the fluorochemical provides the necessary protection.

It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It should also be noted that the term "or" is generally employed in its sense including "and/or" unless the context clearly dictates otherwise.

It should also be noted that, as used in this specification and the appended claims, the phrase "configured to" describes a system, apparatus, or other structure that is constructed or arranged to perform a particular task or take a particular configuration. The phrase "configured to" may be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

As used herein, the recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 2 to 8 includes 2.1, 2.8, 5.3, 7, etc.).

Headings, as used herein, are provided for consistency with recommendations under 37CFR 1.77, or to otherwise provide organizational cues. These headings should not be construed as limiting or characterizing the invention set forth in any claims to which the disclosure may be issued. By way of example, although the headings refer to a "technical field," such claims should not be limited by the language selected under this heading to describe the so-called technical field. Furthermore, the description of technology in the "background" does not constitute an admission that the technology is prior art to any invention in this disclosure. Neither should the "summary" be viewed as characterizing the invention as set forth in the issued claims.

The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may understand and appreciate the principles and practices. Thus, aspects have been described with reference to various specific and preferred embodiments and techniques. It should be understood, however, that many variations and modifications may be made while remaining within the spirit and scope of the disclosure.

Claims

1. A filter assembly for venting gas from an ostomy bag, comprising:

a first layer configured to be gas permeable and liquid impermeable;

an adhesive layer defining at least a first opening;

an adsorption element comprising a gas adsorbing material, the adsorption element disposed between the first layer and the adhesive layer; and

a second layer comprising a material having a melting temperature equal to or lower than 120 ℃ and defining at least a second opening, the second layer being configured to be welded to the ostomy pouch at an annular welding area surrounding the second opening;

wherein the adhesive layer is configured to adhere to the first layer, the absorptive element, and the second layer such that the first opening overlaps the second opening;

wherein the filter assembly is configured such that when the filter assembly is welded to the outlet opening of the ostomy bag, gas from within the ostomy bag flows axially through the sorption element and exits the filter assembly through the second opening; and is

Wherein the perimeters of the first layer, the adhesive layer, and the second layer are substantially aligned.

2. The filter assembly of any of claims 1 and 3-12, the first layer comprising Polytetrafluoroethylene (PTFE).

3. The filter assembly of any of claims 1-2 and 4-12, the first layer comprising a PTFE laminate.

4. The filter assembly of any of claims 1-3 and 5-12, the adhesive layer comprising a double-sided adhesive laminate.

5. The filter assembly of any of claims 1-4 and 6-12, the adhesive layer comprising a pressure sensitive adhesive.

6. The filter assembly of any of claims 1-5 and 7-12, wherein the adhesive layer is a coating on the second layer.

7. The filter assembly of any of claims 1-6 and 8-12, the adsorbent element comprising activated carbon.

8. The filter assembly of any of claims 1-7 and 9-12, the second layer comprising Ethylene Vinyl Acetate (EVA), polyethylene (PE), or polypropylene (PP).

9. The filter assembly of any of claims 1-8 and 10-12, wherein the first opening and the second opening overlap at least about 70% of the length of the adsorbent element.

10. The filter assembly of any of claims 1-9 and 11-12, wherein the first opening and the second opening overlap at least about 25% of an area of a side of the adsorbent element.

11. The filter assembly of any of claims 1-10 and 12, wherein the adhesive layer further defines a third opening and the second layer further defines a fourth opening overlapping the third opening.

12. The filter assembly of claim 11, wherein the first and second overlapping openings define a first filter assembly opening, wherein the third and fourth overlapping openings define a second filter assembly opening, and wherein the first and second filter assembly openings are substantially equal in area.

13. An array of filter assemblies comprising:

a plurality of filter assemblies, each filter assembly comprising:

a first layer configured to be gas permeable and liquid impermeable;

an adhesive layer defining a first opening;

an adsorption element comprising a gas-adsorbing material, the adsorption element disposed between the first layer and the adhesive layer; and

a second layer comprising a material having a melting temperature equal to or lower than 120 ℃ and defining a second opening, the second layer being configured to be welded to an ostomy pouch at an annular welding area surrounding the second opening; and

a carrier comprising a carrier adhesive disposed on a first side of the carrier, wherein each of the filter assemblies is removably attached to the first side of the carrier.

14. The filter assembly array of any of claims 13 and 15-28, wherein the carrier adhesive comprises a low tack adhesive.

15. The filter assembly array of any of claims 13-14 and 16-28, wherein the carrier is wound into a filter assembly supply roll.

16. The filter assembly array of any of claims 13-15 and 17-28, wherein each of the plurality of filter assemblies is configured such that when the filter assembly is welded to the outlet opening of the ostomy bag, gas from within the ostomy bag flows axially through the adsorption element and exits the filter assembly through the second opening.

17. The array of filter elements of any one of claims 13-16 and 18-28, further comprising a gas impermeable barrier layer located between the first layer and the sorption element, the gas impermeable barrier layer configured to block gas flow through the filter element from the direction of the first side of the sorption element, wherein each of the plurality of filter elements is configured such that when the filter element is welded on the exit opening of the ostomy bag, gas from within the ostomy bag flows laterally through the sorption element and exits the filter element through the second opening.

18. The filter assembly array of any of claims 13-17 and 19-28, the first layer comprising Polytetrafluoroethylene (PTFE).

19. The filter assembly array of any of claims 13-18 and 20-28, the first layer comprising a PTFE laminate.

20. The filter assembly array of any of claims 13-19 and 21-28, wherein the adhesive layer comprises a double-sided adhesive laminate.

21. The filter assembly array of any of claims 13-20 and 22-28, wherein the adhesive layer comprises a pressure sensitive adhesive.

22. The filter assembly array of any of claims 13-21 and 23-28, wherein the adhesive layer is a coating on the second layer.

23. An array of filter assemblies as claimed in any one of claims 13 to 22 and 24 to 28, the adsorbent element comprising activated carbon.

24. The filter assembly array of any of claims 13-23 and 25-28, the second layer comprising Ethylene Vinyl Acetate (EVA), polyethylene (PE), or polypropylene (PP).

25. The filter assembly array of any of claims 13-24 and 26-28, wherein the first opening and the second opening overlap at least about 70% of the length of the adsorbent element.

26. The filter assembly array of any of claims 13-25 and 27-28, wherein the first opening and the second opening overlap at least about 25% of an area of a side of the adsorbent element.

27. The filter assembly array of any of claims 13-26 and 28, wherein the adhesive layer further defines a third opening and the second layer further defines a fourth opening overlapping the third opening.

28. The filter assembly array of claim 27, wherein the first and second overlapping openings define a first filter assembly opening, wherein the third and fourth overlapping openings define a second filter assembly opening, and wherein the first and second filter assembly openings are substantially equal in area.

29. A method for producing a filter assembly, comprising:

providing a sheet of a first layer, an adhesive layer, an adsorbent layer, a second layer, and a carrier layer, wherein:

the first layer is configured to be gas permeable and liquid impermeable,

the adsorbent layer includes a gas adsorbent material,

the second layer comprises a material having a melting temperature equal to or lower than 120 ℃, and

the carrier layer includes a carrier adhesive disposed on the adhesive side of the carrier;

bonding the second layer to the adhesive layer;

simultaneously cutting through the second layer and the adhesive layer to form an opening;

removably attaching the second layer to the adhesive side of the carrier layer;

cutting the adsorbent layer into discrete adsorbent elements;

placing one of the discrete adsorbent elements to cover the opening of the adhesive layer;

bonding the first layer to the adhesive layer such that the absorptive element is disposed between the first layer and the second layer; and

a perimeter is formed around the adsorbent element by simultaneously cutting through the first layer, the adhesive layer, and the second layer, resulting in a filter element disposed on the carrier layer.

30. A method for producing a plurality of filter assemblies, comprising:

providing a first layer sheet, an adhesive layer, an adsorbent layer sheet, a second layer sheet, and a carrier sheet, wherein:

the first sheet is configured to be gas permeable and liquid impermeable,

the adsorbent sheet comprises a gas adsorbent material,

the second sheet comprises a material having a melting temperature equal to or lower than 120 ℃, and

the carrier sheet includes a carrier adhesive disposed on the adhesive side of the carrier;

bonding the second ply to the adhesive layer to form a second layer subassembly having a first side and an opposite adhesive layer side;

cutting through the second layer sub-assembly to define a plurality of filter assembly openings in the second layer sub-assembly;

removably attaching the first side of the second layer subassembly to the adhesive side of the carrier sheet to form a first carrier subassembly having a first side and an opposing adhesive layer side;

cutting the absorbent layer sheet into a plurality of absorbent elements;

placing the plurality of adsorbent elements on the adhesive layer side of the first carrier sub-assembly such that each of the plurality of filter assembly openings is covered by one of the plurality of adsorbent elements, thereby forming a second carrier sub-assembly having a first side and an adhesive layer side;

bonding the first layer to the adhesive layer side of the second carrier subassembly such that the adsorbent element is disposed between the first layer and the second layer to form an uncut filter assembly; and

a plurality of filter element disposed on the carrier layer sheet is created by simultaneously cutting through the first layer sheet, the adhesive layer, and the second layer sheet, but not through the carrier layer sheet, forming a plurality of filter assembly perimeters around each of the adsorbent elements.

31. The method of any of claims 30 and 32-35, further comprising rolling the plurality of filter elements disposed on the carrier layer into a filter element supply roll.

32. The method of claim 31, wherein the adhesive layer comprises a pressure sensitive adhesive and winding the plurality of filter elements disposed on the carrier layer into the filter element supply roll compresses the first layer sheet, adhesive layer, and second layer sheet.

33. The method of any of claims 30-32 and 34-35, further comprising unwinding the second layer of sheet material from a second layer supply roll, wherein the second layer of sheet material on the second layer supply roll comprises an adhesive layer on an adhesive layer side.

34. The method of any one of claims 30-33 and 35, further comprising forming the second layer sub-assembly at least 24 hours prior to forming the plurality of filter assembly perimeters.

35. The method of any one of claims 30-34, further comprising forming the plurality of filter element perimeters at least 24 hours before applying a filter element of the plurality of filter elements to an ostomy bag.